BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL2 STD SIZE 15

    MDR report key: 2802789 · Received October 24, 2012

    Report

    Report Number
    1818910-2012-23480
    Event Type
    Injury
    Date Received
    October 24, 2012
    Report Date
    October 5, 2012
    Manufacturer
    DEPUY FRANCE
    Product Code
    KWA
    PMA / PMN Number
    K042992
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    .

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED TO CUSTOMER QUALITY. A REVIEW OF STERILIZATION RECORDS FINDS THE DOSE TO BE WITHIN ALLOWABLE LIMITS AND NO OTHER ANOMALIES WERE FOUND. THE PATIENT WAS IMPLANTED IN (B)(6) 2007 AND REVISED IN (B)(6) 2012. IT IS NOT LIKELY THE DEVICES CONTRIBUTED TO THE PATIENT'S REPORTED INFECTION FIVE YEARS AFTER IMPLANTATION. THE INVESTIGATION CAN DRAW NO CONCLUSIONS WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN IDENTIFIED. IT IS KNOWN THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN AUGUST 2010, AND THE ASR PRODUCT CODES ARE NOW CONSIDERED INACTIVE. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THE PATIENT HAS SUFFERED SEVERE PAIN, CRUNCHING OR POPPING NOISES IN THEIR HIP REGION, DIFFICULTY STANDING OR WALKING, HIP FRACTURES OR DISLOCATIONS, FATIGUE, TISSUE INFLAMMATION, INFECTION, NECROSIS AND METALLOSIS. UPDATE: (B)(6) 2012 - THE SALES REP HAS REPORTED THE REVISION SURGERY. PATIENT WAS REVISED TO ADDRESS PAIN WITH SOME METALLOSIS BEING PRESENT. UPDATE: ((B)(6) 2012) - PATIENT FACT SHEET WAS RECEIVED. THE PART/LOT NUMBERS AND DOI HAVE BEEN UPDATED. DOI: (B)(6) 2007. THE FACT SHEET INDICATED THAT THE PATIENT HAD ANOTHER SURGERY ON (B)(6) 2007 WHERE THE STEM, HEAD AND SLEEVE WERE REMOVED BECAUSE OF INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORAIL2 STD SIZE 15 HIP STEM KWA DEPUY FRANCE 1841226

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention